FDA.reportPublic FDA data

LOTEPREDNOL ETABONATE

Product NDC
0574-4135
11-digit product format
005744135
Labeler code
0574
Product ID
0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA215204
Marketing category
ANDA
Marketing start
2026-01-12
Substance
LOTEPREDNOL ETABONATE
Active strength
5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOTEPREDNOL ETABONATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui311382

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f474382-f6ee-e00d-5df3-bba50cddfd89Product name520251114
64ba4d79-5363-eefc-3390-ee5d2a50a350Product name320250304
100e83dc-ec8c-9e2e-76d2-5112415ec972Product name320241008
4300453c-d545-46d1-b115-18b12b4ccf79Product name120210525
3f316f1c-2561-47c9-9865-ba2be69e0b3eProduct name120190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35Product name120181206
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b5c5cd73-a27b-5e41-bd36-3de9471473cdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-4135-05LOTEPREDNOL ETABONATE1 in 1 CARTONSUSPENSION/ DROPS12
0574-4135-05LOTEPREDNOL ETABONATE5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS52
0574-4135-10LOTEPREDNOL ETABONATE1 in 1 CARTONSUSPENSION/ DROPS12
0574-4135-10LOTEPREDNOL ETABONATE10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS102
0574-4135-15LOTEPREDNOL ETABONATE1 in 1 CARTONSUSPENSION/ DROPS12
0574-4135-15LOTEPREDNOL ETABONATE15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4135-05ML - Milliliter0574-4135ca0fd734-31f5-4895-8636-b9be9e293f0912026-01-08
0574-4135-10ML - Milliliter0574-413544891b33-8412-49a8-8351-6bc59018da6212026-01-08
0574-4135-15ML - Milliliter0574-413544deca5d-8723-4e8a-bc92-49109fc2144212026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSN55ec893d-4955-4d2c-8b5b-84f462d23e022
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCD55ec893d-4955-4d2c-8b5b-84f462d23e022
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSY55ec893d-4955-4d2c-8b5b-84f462d23e022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0574-4135-05005744135051 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPER2026-01-12NoNoCurrent
0574-4135-10005744135101 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPER2026-01-12NoNoCurrent
0574-4135-15005744135151 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPER2026-01-12NoNoCurrent